Kisqali showed encouraging results in HR+/HER2- Early Breast Cancer patients

CAR-T Digest - August 2020

Weekly Digest - 25-31 Mar 2023

27 Mar 2023: Kisqali (Ribociclib) / HR+/HER2- Early Breast Cancer / Novartis: Phase 3 Pivotal NATALEE trial meets primary endpoint of Invasive Disease-free survival

Novartis announced encouraging data from an interim analysis of Phase 3 trial pivotal NATALEE evaluating Kisqali (Ribociclib) plus endocrine therapy (ET)
The Independent Data Monitoring Committee recommended stopping the trial early as the primary endpoint of invasive disease-free survival (iDFS) has been met
Patient follow-up will continue to evaluate long-term outcomes, including overall survival
NATALEE is the first and only positive Phase 3 study of a CDK4/6 inhibitor that demonstrated consistent benefit in a large population of patients with stage II and III HR+/HER2- early breast cancer (EBC)
About 30-60% of people with HR+/HER2- stage II and III EBC treated with ET are at risk of recurrence
“The positive topline results from NATALEE represent a major milestone in our ambition to expand the benefits of Kisqali to patients with earlier stages of breast cancer, building on the heritage of this effective treatment in HR+/HER2- metastatic breast cancer,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis
NATALEE results will be presented at an upcoming medical meeting and submitted to regulatory authorities worldwide